EU Falsified Medicines Directive - Is Europe ready?

Added:
03.09.2017By:
Anne-Marie Murphy

PPMA 2017 took place in Birmingham from September 26th - 28th. Dan Anslow, Crest Solutions UK Sales Manager, was invited to speak on Day 3 on the realities of implementing solutions for Serialisation, Aggregation and Track & Trace.

Dan shared with his audience insights from companies who have already implemented serialisation projects in the hope that those who still need to begin such a journey can avoid common pitfalls and benefit from the identified areas of good practice.

Here are the key takeaways from Dan's talk:

Serialisation and the EU-FMD

To avoid both product contamination and product counterfeiting many countries have introduced regulation, typically referred to as “Track and Trace” or “Serialisation” which protects the integrity of a bone fide pharmaceutical carton or bottle.

In the case of the European Falsified Medicines Directive, the regulation deadline is the 9th of February 2019.

The EU-FMD pertains specifically to the lowest saleable item of prescription medicine, which requires a unique reference number or “Serialisation Number” which is displayed as human readable text and embedded within a 2D matrix.

The carton or bottle must also must contain Anti-Tamper Evidence.

The unique codes will be transferred to the EMVO, commonly known as the European Hub, which will then transfer the codes to the relevant national hubs where the product will be sold.

At the end of the supply chain a pharmacist will scan the 2D bar code and in real time check with the National Hub that the code is bone fide before releasing to the patient.

The 3 components of a successful Serialisation implementation

There are 3 key components of Serialisation, and they might not be what you expect:

Stakeholder engagement

Vendor selection & relationship

Staff training

Things to watch out for

Ensure your team is on board, and that all the relevant stakeholders and teams have a clear understanding of the scale and impact of this project to be undertaken.

When selecting a vendor, consider location and their ability to support your site on the ground.

As regulations in this sector are evolving, technology can be immature and, with the best of intentions, vendors can over-promise.

Visits to reference sites for other customers who have already implemented a particular technology are a must!

Your team of line operators will appreciate an understanding and training in this technology.

Dan's talk also brought us through specific examples of successes and pitfalls that you can watch out for when implementing solutions for Serialisation and Track & Trace.